The following data is part of a premarket notification filed by Long Fortune Industries Ltd. with the FDA for Longfortune Patient Exam Gloves.
| Device ID | K892980 |
| 510k Number | K892980 |
| Device Name: | LONGFORTUNE PATIENT EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | LONG FORTUNE INDUSTRIES LTD. 432 N. CANAL ST. SUITE #2 South San Francisco, CA 94080 |
| Contact | Haim Samucha |
| Correspondent | Haim Samucha LONG FORTUNE INDUSTRIES LTD. 432 N. CANAL ST. SUITE #2 South San Francisco, CA 94080 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-12 |
| Decision Date | 1989-07-31 |